The Office of Human Research Ethics (OHRE) is responsible for ethical and regulatory oversight of research at UNC-Chapel Hill that involves human subjects. OHRE administers, supports, guides and oversees the work of the Institutional Review Boards (IRBs), and all related activities. These IRBs are federally mandated review committees, operating under regulations from the Office for Human Research Protections (OHRP, DHHS) and the Food and Drug Administration (FDA). The OHRE and IRBs are critical components of a program that serves to protect the rights and welfare of human research subjects. All components of this program, coordinated through the OHRE, must work together to ensure institutional compliance with ethical principles and regulatory requirements.
Additionally, in accordance with the mission of OHRE, the goals are to ensure compliance with federal regulations and university policy, and to promote best practices in human research protections. This can best be accomplished by consistent application of policies and procedures and standardized documentation of IRB actions.
This position is responsible for oversight, management and support of regulatory affairs and compliance within the Office of Human Research Ethics (OHRE).
Education and Experience:
At least five years’ experience with Institutional Review Boards, preferably in a senior managerial capacity. Ability to communicate effectively in both writing and orally, inside and outside the University. This includes interactions that will represent UNC-CH nationally, as well as internal interactions with other administrators and researchers. Working knowledge of the federal regulations that govern research involving human subjects, including FDA (21 CFR 50 and 56), HHS (45 CFR 46) and HIPAA (45 CFR 160 and 164). Familiarity with international standards for human research is desirable. Experience in executing reliance agreements, both as a reviewing and relying IRB and ensuring appropriate local context review requirements. Experience in reviewing adverse events and comprehensive knowledge of reporting requirements.
The University of North Carolina at Chapel Hill is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or status as a protected veteran.
Internal Number: 171050
About The University of North Carolina at Chapel Hill
Carolina rates among the nation’s great institutions of higher education, set on an historic and beautiful campus that celebrates all four seasons. Carolina’s students, faculty and staff come here from around the world, bringing varied cultural, racial and ethnic heritages that help make UNC-Chapel Hill a thriving intellectual center. We’re repeatedly ranked the nation’s best value in higher education for students seeking to earn a college degree – the University has garnered the top spot each time since the ranking’s launch in 1998.Whether you’ve just started your career, are new to academia or are a seasoned professional with assorted campus experiences to draw on, we hope you will find a great place at Carolina.